The present invention relates to an endovascular device for filling of a vascular pathology, or other pathologic outpouchings, such as an intracranial aneurysm.
Present actions for ameliorating cerebral aneurysms is performed by either an open surgical clipping of the aneurysm or via interventional endovascular procedures. The most typical of such procedures involves the placement of one or more coils within the aneurysmal sac via a microcatheter. The primary limitation associated with said procedures is the fact so called “wide-necked” aneurysms are not generally amenable to this type of treatment due to the likelihood that the devices associated with said procedures will be displaced from the aneurysm sac. Another limitation associated with procedures which use a single thread coil device is that said device usually requires the surgeon to pack said coil within the aneurysm and thereby increasing the risk of damaging both the vessel and the aneurysm walls.
The prior art discloses the use of intracranial stents that have been developed for placement in the parent blood vessel to act as a buttress for holding the coil(s) in place within the aneurysmal sac in an effort to improve the retention of coils in aneurysms exhibiting such wide-necked anatomy. The fact that said stents must be placed in the brain is a limitation to this approach, due to the medical difficulties associated with damaging the blood vessels of the brain and increasing morbidity in both the short term as well as resulting in post-operative intracranial stenosis. Additionally, placement of such stents requires the use of oral dual antiplatelet therapy, to prevent in-stent thrombosis. The medications have potential bleeding complications. Furthermore, these medications are relatively contraindicated in the setting of a ruptured intracranial aneurysm, which often precludes the use of such stents in these settings.
While the prior art discloses the use of self-expanding coils such as US20100069948A1—Erol Veznedaroglu, said prior art discloses fail to provide a structure which decreases the permeability of blood across the neck of the aneurysm, thus resulting in higher rates of coil compaction within said aneurysm, and aneurysmal recurrence with its attendant risks. The present invention employs a mesh element, positioned predominantly across the neck of the aneurysm/out-pouching to surmount said limitation.
While the prior art discloses the use of a self-expanding mesh disc, positioned across the neck of aneurysm, for example U.S. patent application Ser. No. 15/732,519 (Walzman '519), said prior-art disclosures fail to provide a structure which is immediately stabilized due to the lack of positioning elements suitable for gripping the aneurysmal wall. This lack of immediately stabilizing capability can result in the displacement of the device, thus necessitating the closing of said device, reposition of said device and redeployment of said device. Said closing, repositioning and redeploying takes time (when time is usually of the essence when dealing with aneurisms) and tends to damage vessel walls. Additionally, if said mesh disc apparatus is displaced after additional coils are deployed, repositioning of said apparatus may not be possible, and the malposition may result in permanent injury to the patient. The present invention employs mesh element as well as components that secure its position with said aneurysm before detachment, and before placement of additional embolic materials when needed, to surmount said limitation. Thus, a self-expandable aneurysm filling device the can both cover the neck of an aneurysm and serve as a permanent embolic plug in the aneurysm is desirable which is immediately stabilized. The present invention meets these and other needs. Thus, a self-expandable aneurysm filling device the can both cover the neck of an aneurysm and serve as a permanent embolic plug in the aneurysm, with elements that promptly stabilize its position, with the mesh component in its desired position across the neck of the aneurysm, but not projecting into the parent vessel, is desirable. The present invention meets these and other needs.